S 1890 IS
105th CONGRESS
2d Session
S. 1890
To amend the
Public Health Service Act and the Employee Retirement Income Security Act of
1974 to protect consumers in managed care plans and other health coverage.
IN THE SENATE OF THE
UNITED STATES
March 31, 1998
Mr. DASCHLE (for himself,
Mr. KENNEDY, Mrs. BOXER, Mr. DODD, Ms. MIKULSKI, Mrs. FEINSTEIN, Mr. DURBIN,
Mr. REED, Mr. INOUYE, Mr. TORRICELLI, Mr. KERRY, Ms. MOSELEY-BRAUN, Mr. WYDEN,
Mr. LAUTENBERG, Mr. ROCKEFELLER, Mr. CLELAND, Mr. LEAHY, Mrs. MURRAY, Mr. WELLSTONE,
Mr. SARBANES, Mr. AKAKA, and Mr. BINGAMAN) introduced the following bill; which
was read twice and referred to the Committee on Labor and Human Resources
A BILL
To amend the
Public Health Service Act and the Employee Retirement Income Security Act of
1974 to protect consumers in managed care plans and other health coverage.
Be it enacted by
the Senate and House of Representatives of the United States of America in Congress
assembled,
SECTION 1. SHORT TITLE;
TABLE OF CONTENTS.
(a) SHORT TITLE- This
Act may be cited as the `Patients' Bill of Rights Act of 1998'.
(b) TABLE OF CONTENTS-
The table of contents of this Act is as follows:
Sec. 1. Short title;
table of contents.
TITLE I--HEALTH INSURANCE
BILL OF RIGHTS
Subtitle A--Access to
Care
Sec. 101. Access to
emergency care.
Sec. 102. Offering
of choice of coverage options under group health plans.
Sec. 103. Choice of
providers.
Sec. 104. Access to
specialty care.
Sec. 105. Continuity
of care.
Sec. 106. Coverage
for individuals participating in approved clinical trials.
Sec. 107. Access to
needed prescription drugs.
Sec. 108. Adequacy
of provider network.
Sec. 109. Nondiscrimination
in delivery of services.
Subtitle B--Quality
Assurance
Sec. 111. Internal
quality assurance program.
Sec. 112. Collection
of standardized data.
Sec. 113. Process for
selection of providers.
Sec. 114. Drug utilization
program.
Sec. 115. Standards
for utilization review activities.
Sec. 116. Health Care
Quality Advisory Board.
Subtitle C--Patient
Information
Sec. 121. Patient information.
Sec. 122. Protection
of patient confidentiality.
Sec. 123. Health insurance
ombudsmen.
Subtitle D--Grievance
and Appeals Procedures
Sec. 131. Establishment
of grievance process.
Sec. 132. Internal
appeals of adverse determinations.
Sec. 133. External
appeals of adverse determinations.
Subtitle E--Protecting
the Doctor-Patient Relationship
Sec. 141. Prohibition
of interference with certain medical communications.
Sec. 142. Prohibition
against transfer of indemnification or improper incentive arrangements.
Sec. 143. Additional
rules regarding participation of health care professionals.
Sec. 144. Protection
for patient advocacy.
Subtitle F--Promoting
Good Medical Practice
Sec. 151. Promoting
good medical practice.
Sec. 152. Standards
relating to benefits for certain breast cancer treatment.
Sec. 153. Standards
relating to benefits for reconstructive breast surgery.
Subtitle G--Definitions
Sec. 192. Preemption;
State flexibility; construction.
TITLE II--APPLICATION
OF PATIENT PROTECTION STANDARDS TO GROUP HEALTH PLANS AND HEALTH INSURANCE COVERAGE
UNDER PUBLIC HEALTH SERVICE ACT
Sec. 201. Application
to group health plans and group health insurance coverage.
Sec. 202. Application
to individual health insurance coverage.
TITLE III--AMENDMENTS
TO THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974
Sec. 301. Application
of patient protection standards to group health plans and group health insurance
coverage under the Employee Retirement Income Security Act of 1974.
Sec. 302. ERISA preemption
not to apply to certain actions involving health insurance policyholders.
TITLE IV--EFFECTIVE
DATES; COORDINATION IN IMPLEMENTATION.
Sec. 401. Effective
dates.
Sec. 402. Coordination
in implementation.
TITLE I--HEALTH INSURANCE
BILL OF RIGHTS
Subtitle A--Access
to Care
SEC. 101. ACCESS TO
EMERGENCY CARE.
(a) COVERAGE OF EMERGENCY
SERVICES-
(1) IN GENERAL- If
a group health plan, or health insurance coverage offered by a health insurance
issuer, provides any benefits with respect to emergency services (as defined
in paragraph (2)(B)), the plan or issuer shall cover emergency services furnished
under the plan or coverage--
(A) without the need
for any prior authorization determination;
(B) whether or not
the health care provider furnishing such services is a participating provider
with respect to such services;
(C) in a manner so
that, if such services are provided to a participant, beneficiary, or enrollee
by a nonparticipating health care provider--
(i) the participant,
beneficiary, or enrollee is not liable for amounts that exceed the amounts
of liability that would be incurred if the services were provided by a
participating health care provider, and
(ii) the plan or
issuer pays an amount that is not less than the amount paid to a participating
health care provider for the same services; and
(D) without regard
to any other term or condition of such coverage (other than exclusion or
coordination of benefits, or an affiliation or waiting period, permitted
under section 2701 of the Public Health Service Act, section 701 of the
Employee Retirement Income Security Act of 1974, or section 9801 of the
Internal Revenue Code of 1986, and other than applicable cost-sharing).
(2) DEFINITIONS- In
this section:
(A) EMERGENCY MEDICAL
CONDITION BASED ON PRUDENT LAYPERSON STANDARD- The term `emergency medical
condition' means a medical condition manifesting itself by acute symptoms
of sufficient severity (including severe pain) such that a prudent layperson,
who possesses an average knowledge of health and medicine, could reasonably
expect the absence of immediate medical attention to result in a condition
described in clause (i), (ii), or (iii) of section 1867(e)(1)(A) of the
Social Security Act.
(B) EMERGENCY SERVICES-
The term `emergency services' means--
(i) a medical screening
examination (as required under section 1867 of the Social Security Act)
that is within the capability of the emergency department of a hospital,
including ancillary services routinely available to the emergency department
to evaluate an emergency medical condition (as defined in subparagraph
(A)), and
(ii) within the
capabilities of the staff and facilities available at the hospital, such
further medical examination and treatment as are required under section
1867 of such Act to stabilize the patient.
(b) REIMBURSEMENT FOR
MAINTENANCE CARE AND POST-STABILIZATION CARE- In the case of services (other
than emergency services) for which benefits are available under a group health
plan, or under health insurance coverage offered by a health insurance issuer,
the plan or issuer shall provide for reimbursement with respect to such services
provided to a participant, beneficiary, or enrollee other than through a participating
health care provider in a manner consistent with subsection (a)(1)(C) if the
services are maintenance care or post-stabilization care covered under the guidelines
established under section 1852(d)(2) of the Social Security Act (relating to
promoting efficient and timely coordination of appropriate maintenance and post-stabilization
care of an enrollee after an enrollee has been determined to be stable), or,
in the absence of guidelines under such section, such guidelines as the Secretary
shall establish to carry out this subsection.
SEC. 102. OFFERING OF
CHOICE OF COVERAGE OPTIONS UNDER GROUP HEALTH PLANS.
(1) OFFERING OF POINT-OF-SERVICE
COVERAGE OPTION- Except as provided in paragraph (2), if a group health plan
(or health insurance coverage offered by a health insurance issuer in connection
with a group health plan) provides benefits only through participating health
care providers, the plan or issuer shall offer the participant the option
to purchase point-of-service coverage (as defined in subsection (b)) for all
such benefits for which coverage is otherwise so limited. Such option shall
be made available to the participant at the time of enrollment under the plan
or coverage and at such other times as the plan or issuer offers the participant
a choice of coverage options.
(2) EXCEPTION- Paragraph
(1) shall not apply with respect to a participant in a group health plan if
the plan offers the participant--
(A) a choice of health
insurance coverage through more than one health insurance issuer; or
(B) two or more coverage
options that differ significantly with respect to the use of participating
health care providers or the networks of such providers that are used.
(b) POINT-OF-SERVICE
COVERAGE DEFINED- In this section, the term `point-of-service coverage' means,
with respect to benefits covered under a group health plan or health insurance
issuer, coverage of such benefits when provided by a nonparticipating health
care provider. Such coverage need not include coverage of providers that the
plan or issuer excludes because of fraud, quality, or similar reasons.
(c) CONSTRUCTION- Nothing
in this section shall be construed--
(1) as requiring coverage
for benefits for a particular type of health care provider;
(2) as requiring an
employer to pay any costs as a result of this section or to make equal contributions
with respect to different health coverage options; or
(3) as preventing a
group health plan or health insurance issuer from imposing higher premiums
or cost-sharing on a participant for the exercise of a point-of-service coverage
option.
(d) NO REQUIREMENT FOR
GUARANTEED AVAILABILITY- If a health insurance issuer offers health insurance
coverage that includes point-of-service coverage with respect to an employer
solely in order to meet the requirement of subsection (a), nothing in section
2711(a)(1)(A) of the Public Health Service Act shall be construed as requiring
the offering of such coverage with respect to another employer.
SEC. 103. CHOICE OF
PROVIDERS.
(a) PRIMARY CARE- A group
health plan, and a health insurance issuer that offers health insurance coverage,
shall permit each participant, beneficiary, and enrollee to receive primary
care from any participating primary care provider who is available to accept
such individual.
(1) IN GENERAL- Subject
to paragraph (2), a group health plan and a health insurance issuer that offers
health insurance coverage shall permit each participant, beneficiary, or enrollee
to receive medically necessary or appropriate specialty care, pursuant to
appropriate referral procedures, from any qualified participating health care
provider who is available to accept such individual for such care.
(2) LIMITATION- Paragraph
(1) shall not apply to specialty care if the plan or issuer clearly informs
participants, beneficiaries, and enrollees of the limitations on choice of
participating providers with respect to such care.
SEC. 104. ACCESS TO
SPECIALTY CARE.
(a) OBSTETRICAL AND GYNECOLOGICAL
CARE-
(1) IN GENERAL- If
a group health plan, or a health insurance issuer in connection with the provision
of health insurance coverage, requires or provides for a participant, beneficiary,
or enrollee to designate a participating primary care provider--
(A) the plan or issuer
shall permit such an individual who is a female to designate a participating
physician who specializes in obstetrics and gynecology as the individual's
primary care provider; and
(B) if such an individual
has not designated such a provider as a primary care provider, the plan
or issuer--
(i) may not require
authorization or a referral by the individual's primary care provider
or otherwise for coverage of routine gynecological care (such as preventive
women's health examinations) and pregnancy-related services provided by
a participating health care professional who specializes in obstetrics
and gynecology to the extent such care is otherwise covered, and
(ii) may treat
the ordering of other gynecological care by such a participating physician
as the authorization of the primary care provider with respect to such
care under the plan or coverage.
(2) CONSTRUCTION- Nothing
in paragraph (1)(B)(ii) shall waive any requirements of coverage relating
to medical necessity or appropriateness with respect to coverage of gynecological
care so ordered.
(1) SPECIALTY CARE
FOR COVERED SERVICES-
(i) an individual
is a participant or beneficiary under a group health plan or an enrollee
who is covered under health insurance coverage offered by a health insurance
issuer,
(ii) the individual
has a condition or disease of sufficient seriousness and complexity to
require treatment by a specialist, and
(iii) benefits
for such treatment are provided under the plan or coverage,
the plan or issuer
shall make or provide for a referral to a specialist who is available and
accessible to provide the treatment for such condition or disease.
(B) SPECIALIST DEFINED-
For purposes of this subsection, the term `specialist' means, with respect
to a condition, a health care practitioner, facility, or center (such as
a center of excellence) that has adequate expertise through appropriate
training and experience (including, in the case of a child, appropriate
pediatric expertise) to provide high quality care in treating the condition.
(C) CARE UNDER REFERRAL-
A group health plan or health insurance issuer may require that the care
provided to an individual pursuant to such referral under subparagraph (A)
be--
(i) pursuant to
a treatment plan, only if the treatment plan is developed by the specialist
and approved by the plan or issuer, in consultation with the designated
primary care provider or specialist and the individual (or the individual's
designee), and
(ii) in accordance
with applicable quality assurance and utilization review standards of
the plan or issuer.
Nothing in this subsection
shall be construed as preventing such a treatment plan for an individual
from requiring a specialist to provide the
primary care provider
with regular updates on the specialty care provided, as well as all necessary
medical information.
(D) REFERRALS TO
PARTICIPATING PROVIDERS- A group health plan or health insurance issuer
is not required under subparagraph (A) to provide for a referral to a specialist
that is not a participating provider, unless the plan or issuer does not
have an appropriate specialist that is available and accessible to treat
the individual's condition and that is a participating provider with respect
to such treatment.
(E) TREATMENT OF
NONPARTICIPATING PROVIDERS- If a plan or issuer refers an individual to
a nonparticipating specialist pursuant to subparagraph (A), services provided
pursuant to the approved treatment plan (if any) shall be provided at no
additional cost to the individual beyond what the individual would otherwise
pay for services received by such a specialist that is a participating provider.
(2) SPECIALISTS AS
PRIMARY CARE PROVIDERS-
(A) IN GENERAL- A
group health plan, or a health insurance issuer, in connection with the
provision of health insurance coverage, shall have a procedure by which
an individual who is a participant, beneficiary, or enrollee and who has
an ongoing special condition (as defined in subparagraph (C)) may receive
a referral to a specialist for such condition who shall be responsible for
and capable of providing and coordinating the individual's primary and specialty
care. If such an individual's care would most appropriately be coordinated
by such a specialist, such plan or issuer shall refer the individual to
such specialist.
(B) TREATMENT AS
PRIMARY CARE PROVIDER- Such specialist shall be permitted to treat the individual
without a referral from the individual's primary care provider and may authorize
such referrals, procedures, tests, and other medical services as the individual's
primary care provider would otherwise be permitted to provide or authorize,
subject to the terms of the treatment plan (referred to in paragraph (1)(C)(i)).
(C) ONGOING SPECIAL
CONDITION DEFINED- In this paragraph, the term `special condition' means
a condition or disease that--
(i) is life-threatening,
degenerative, or disabling, and
(ii) requires specialized
medical care over a prolonged period of time.
(D) TERMS OF REFERRAL-
The provisions of subparagraphs (C) through (E) of paragraph (1) apply with
respect to referrals under subparagraph (A) of this paragraph in the same
manner as they apply to referrals under paragraph (1)(A).
(A) IN GENERAL- A
group health plan, and a health insurance issuer in connection with the
provision of health insurance coverage, shall have a procedure by which
an individual who is a participant, beneficiary, or enrollee and who has
a condition that requires ongoing care from a specialist may receive a standing
referral to such specialist for treatment of such condition. If the plan
or issuer, or if the primary care provider in consultation with the medical
director of the plan or issuer and the specialist (if any), determines that
such a standing referral is appropriate, the plan or issuer shall make such
a referral to such a specialist.
(B) TERMS OF REFERRAL-
The provisions of subparagraphs (C) through (E) of paragraph (1) apply with
respect to referrals under subparagraph (A) of this paragraph in the same
manner as they apply to referrals under paragraph (1)(A).
SEC. 105. CONTINUITY
OF CARE.
(1) TERMINATION OF
PROVIDER- If a contract between a group health plan, or a health insurance
issuer in connection with the provision of health insurance coverage, and
a health care provider is terminated (as defined in paragraph (3)), or benefits
or coverage provided by a health care provider are terminated because of a
change in the terms of provider participation in a group health plan, and
an individual who is a participant, beneficiary, or enrollee in the plan or
coverage is undergoing a course of treatment from the provider at the time
of such termination, the plan or issuer shall--
(A) notify the individual
on a timely basis of such termination, and
(B) subject to subsection
(c), permit the individual to continue or be covered with respect to the
course of treatment with the provider during a transitional period (provided
under subsection (b)).
(2) TREATMENT OF TERMINATION
OF CONTRACT WITH HEALTH INSURANCE ISSUER- If a contract for the provision
of health insurance coverage between a group health plan and a health insurance
issuer is terminated and, as a result of such termination, coverage of services
of a health care provider is terminated with respect to an individual, the
provisions of paragraph (1) (and the succeeding provisions of this section)
shall apply under the plan in the same manner as if there had been a contract
between the plan and the provider that had been terminated, but only with
respect to benefits that are covered under the plan after the contract termination.
(3) TERMINATION- In
this section, the term `terminated' includes, with respect to a contract,
the expiration or nonrenewal of the contract, but does not include a termination
of the contract by the plan or issuer for failure to meet applicable quality
standards or for fraud.
(1) IN GENERAL- Except
as provided in paragraphs (2) through (4), the transitional period under this
subsection shall extend for at least 90 days from the date of the notice described
in subsection (a)(1)(A) of the provider's termination.
(2) INSTITUTIONAL CARE-
The transitional period under this subsection for institutional or inpatient
care from a provider shall extend until the discharge or termination of the
period of institutionalization and also shall include institutional care provided
within a reasonable time of the date of termination of the provider status
if the care was scheduled before the date of the announcement of the termination
of the provider status under subsection (a)(1)(A) or if the individual on
such date was on an established waiting list or otherwise scheduled to have
such care.
(A) a participant,
beneficiary, or enrollee has entered the second trimester of pregnancy at
the time of a provider's termination of participation, and
(B) the provider
was treating the pregnancy before date of the termination,
the transitional period
under this subsection with respect to provider's treatment of the pregnancy
shall extend through the provision of post-partum care directly related to
the delivery.
(4) TERMINAL ILLNESS-
If--
(A) a participant,
beneficiary, or enrollee was determined to be terminally ill (as determined
under section 1861(dd)(3)(A) of the Social Security Act) at the time of
a provider's termination of participation, and
(B) the provider
was treating the terminal illness before the date of termination,
the transitional period
under this subsection shall extend for the remainder of the individual's life
for care directly related to the treatment of the terminal illness.
(c) PERMISSIBLE TERMS
AND CONDITIONS- A group health plan or health insurance issuer may condition
coverage of continued treatment by a provider under subsection (a)(1)(B) upon
the provider agreeing to the following terms and conditions:
(1) The provider agrees
to accept reimbursement from the plan or issuer and individual involved (with
respect to cost-sharing) at the rates applicable prior to the start of the
transitional period as payment in full (or, in the case described in subsection
(a)(2), at the rates applicable under the replacement plan or issuer after
the date of the termination of the contract with the health insurance issuer)
and not to impose cost-sharing with respect to the individual in an amount
that would exceed the cost-sharing that could have been imposed if the contract
referred to in subsection (a)(1) had not been terminated.
(2) The provider agrees
to adhere to the quality assurance standards of the plan or issuer responsible
for payment under paragraph (1) and to provide to such plan or issuer necessary
medical information related to the care provided.
(3) The provider agrees
otherwise to adhere to such plan's or issuer's policies and procedures, including
procedures regarding referrals and obtaining prior authorization and providing
services pursuant to a treatment plan (if any) approved by the plan or issuer.
(d) CONSTRUCTION- Nothing
in this section shall be construed to require the coverage of benefits which
would not have been covered if the provider involved remained a participating
provider.
SEC. 106. COVERAGE FOR
INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL TRIALS.
(1) IN GENERAL- If
a group health plan, or health insurance issuer that is providing health insurance
coverage, provides coverage to a qualified individual (as defined in subsection
(b)), the plan or issuer--
(A) may not deny
the individual participation in the clinical trial referred to in subsection
(b)(2);
(B) subject to subsection
(c), may not deny (or limit or impose additional conditions on) the coverage
of routine patient costs for items and services furnished in connection
with participation in the trial; and
(C) may not discriminate
against the individual on the basis of the enrollee's participation in such
trial.
(2) EXCLUSION OF CERTAIN
COSTS- For purposes of paragraph (1)(B), routine patient costs do not include
the cost of the tests or measurements conducted primarily for the purpose
of the clinical trial involved.
(3) USE OF IN-NETWORK
PROVIDERS- If one or more participating providers is participating in a
clinical trial, nothing
in paragraph (1) shall be construed as preventing a plan or issuer from requiring
that a qualified individual participate in the trial through such a participating
provider if the provider will accept the individual as a participant in the
trial.
(b) QUALIFIED INDIVIDUAL
DEFINED- For purposes of subsection (a), the term `qualified individual' means
an individual who is a participant or beneficiary in a group health plan, or
who is an enrollee under health insurance coverage, and who meets the following
conditions:
(1)(A) The individual
has a life-threatening or serious illness for which no standard treatment
is effective.
(B) The individual
is eligible to participate in an approved clinical trial according to the
trial protocol with respect to treatment of such illness.
(C) The individual's
participation in the trial offers meaningful potential for significant clinical
benefit for the individual.
(A) the referring
physician is a participating health care professional and has concluded
that the individual's participation in such trial would be appropriate based
upon the individual meeting the conditions described in paragraph (1); or
(B) the participant,
beneficiary, or enrollee provides medical and scientific information establishing
that the individual's participation in such trial would be appropriate based
upon the individual meeting the conditions described in paragraph (1).
(1) IN GENERAL- Under
this section a group health plan or health insurance issuer shall provide
for payment for routine patient costs described in subsection (a)(2) but is
not required to pay for costs of items and services that are reasonably expected
(as determined by the Secretary) to be paid for by the sponsors of an approved
clinical trial.
(2) PAYMENT RATE- In
the case of covered items and services provided by--
(A) a participating
provider, the payment rate shall be at the agreed upon rate, or
(B) a nonparticipating
provider, the payment rate shall be at the rate the plan or issuer would
normally pay for comparable services under subparagraph (A).
(d) APPROVED CLINICAL
TRIAL DEFINED-
(1) IN GENERAL- In
this section, the term `approved clinical trial' means a clinical research
study or clinical investigation approved and funded (which may include funding
through in-kind contributions) by one or more of the following:
(A) The National
Institutes of Health.
(B) A cooperative
group or center of the National Institutes of Health.
(C) Either of the
following if the conditions described in paragraph (2) are met:
(i) The Department
of Veterans Affairs.
(ii) The Department
of Defense.
(2) CONDITIONS FOR
DEPARTMENTS- The conditions described in this paragraph, for a study or investigation
conducted by a Department, are that the study or investigation has been reviewed
and approved through a system of peer review that the Secretary determines--
(A) to be comparable
to the system of peer review of studies and investigations used by the National
Institutes of Health, and
(B) assures unbiased
review of the highest scientific standards by qualified individuals who
have no interest in the outcome of the review.
(e) CONSTRUCTION- Nothing
in this section shall be construed to limit a plan's or issuer's coverage with
respect to clinical trials.
SEC. 107. ACCESS TO
NEEDED PRESCRIPTION DRUGS.
(a) IN GENERAL- If a
group health plan, or health insurance issuer that offers health insurance coverage,
provides benefits with respect to prescription drugs but the coverage limits
such benefits to drugs included in a formulary, the plan or issuer shall--
(1) ensure participation
of participating physicians and pharmacists in the development of the formulary;
(2) disclose to providers
and, disclose upon request under section 121(c)(6) to participants, beneficiaries,
and enrollees, the nature of the formulary restrictions; and
(3) consistent with
the standards for a utilization review program under section 115, provide
for exceptions from the formulary limitation when a non-formulary alternative
is medically indicated.
(b) COVERAGE OF APPROVED
DRUGS AND MEDICAL DEVICES-
(1) IN GENERAL- A group
health plan (or health insurance coverage offered in connection with such
a plan) that provides any coverage of prescription drugs or medical devices
shall not deny coverage of such a drug or device on the basis that the use
is investigational, if the use--
(A) in the case of
a prescription drug--
(i) is included
in the labeling authorized by the application in effect for the drug pursuant
to subsection (b) or (j) of section 505 of the Federal Food, Drug, and
Cosmetic Act, without regard to any postmarketing requirements that may
apply under such Act; or
(ii) is included
in the labeling authorized by the application in effect for the drug under
section 351 of the Public Health Service Act, without regard to any postmarketing
requirements that may apply pursuant to such section; or
(B) in the case of
a medical device, is included in the labeling authorized by a regulation
under subsection (d) or (3) of section 513 of the Federal Food, Drug, and
Cosmetic Act, an order under subsection (f) of such section, or an application
approved under section 515 of such Act, without regard to any postmarketing
requirements that may apply under such Act.
(2) CONSTRUCTION- Nothing
in this subsection shall be construed as requiring a group health plan (or
health insurance coverage offered in connection with such a plan) to provide
any coverage of prescription drugs or medical devices.
SEC. 108. ADEQUACY OF
PROVIDER NETWORK.
(a) IN GENERAL- Each
group health plan, and each health insurance issuer offering health insurance
coverage, that provides benefits, in whole or in part, through participating
health care providers shall have (in relation to the coverage) a sufficient
number, distribution, and variety of qualified participating health care providers
to ensure that all covered health care services, including specialty services,
will be available and accessible in a timely manner to all participants, beneficiaries,
and enrollees under the plan or coverage.
(b) TREATMENT OF CERTAIN
PROVIDERS- The qualified health care providers under subsection (a) may include
Federally qualified health centers, rural health clinics, migrant health centers,
and other essential community providers located in the service area of the plan
or issuer and shall include such providers if necessary to meet the standards
established to carry out such subsection.
SEC. 109. NONDISCRIMINATION
IN DELIVERY OF SERVICES.
(a) APPLICATION TO DELIVERY
OF SERVICES- Subject to subsection (b), a group health plan, and health insurance
issuer in relation to health insurance coverage, may not discriminate against
a participant, beneficiary, or enrollee in the delivery of health care services
consistent with the benefits covered under the plan or coverage or as required
by law based on race, color, ethnicity, national origin, religion, sex, age,
mental or physical disability, sexual orientation, genetic information, or source
of payment.
(b) CONSTRUCTION- Nothing
in subsection (a) shall be construed as relating to the eligibility to be covered,
or the offering (or guaranteeing the offer) of coverage, under a plan or health
insurance coverage, the application of any pre-existing condition exclusion
consistent with applicable law, or premiums charged under such plan or coverage.
Subtitle B--Quality
Assurance
SEC. 111. INTERNAL QUALITY
ASSURANCE PROGRAM.
(a) REQUIREMENT- A group
health plan, and a health insurance issuer that offers health insurance coverage,
shall establish and maintain an ongoing, internal quality assurance and continuous
quality improvement program that meets the requirements of subsection (b).
(b) PROGRAM REQUIREMENTS-
The requirements of this subsection for a quality improvement program of a plan
or issuer are as follows:
(1) ADMINISTRATION-
The plan or issuer has a separate identifiable unit with responsibility for
administration of the program.
(2) WRITTEN PLAN- The
plan or issuer has a written plan for the program that is updated annually
and that specifies at least the following:
(A) The activities
to be conducted.
(B) The organizational
structure.
(C) The duties of
the medical director.
(D) Criteria and
procedures for the assessment of quality.
(3) SYSTEMATIC REVIEW-
The program provides for systematic review of the type of health services
provided, consistency of services provided with good medical practice, and
patient outcomes.
(4) QUALITY CRITERIA-
The program--
(A) uses criteria
that are based on performance and patient outcomes where feasible and appropriate;
(B) includes criteria
that are directed specifically at meeting the needs of at-risk populations
and covered individuals with chronic conditions or severe illnesses, including
gender-specific criteria and pediatric-specific criteria where available
and appropriate;
(C) includes methods
for informing covered individuals of the benefit of preventive care and
what specific benefits with respect to preventive care are covered under
the plan or coverage; and
(D) makes available
to the public a description of the criteria used under subparagraph (A).
(5) SYSTEM FOR REPORTING-
The program has procedures for reporting of possible quality concerns by providers
and enrollees and for remedial actions to correct quality problems, including
written procedures for responding to concerns and taking appropriate corrective
action.
(6) DATA ANALYSIS-
The program provides, using data that include the data collected under section
112, for an analysis of the plan's or issuer's performance on quality measures.
(7) DRUG UTILIZATION
REVIEW- The program provides for a drug utilization review program in accordance
with section 114.
(c) DEEMING- For purposes
of subsection (a), the requirements of--
(1) subsection (b)
(other than paragraph (5)) are deemed to be met with respect to a health insurance
issuer that is a qualified health maintenance organization (as defined in
section 1310(c) of the Public Health Service Act); or
(2) subsection (b)
are deemed to be met with respect to a health insurance issuer that is accredited
by a national accreditation organization that the Secretary certifies as applying,
as a condition of certification, standards at least as stringent as those
required for a quality improvement program under subsection (b).
(d) VARIATION PERMITTED-
The Secretary may provide for variations in the application of the requirements
of this section to group health plans and health insurance issuers based upon
differences in the delivery system among such plans and issuers as the Secretary
deems appropriate.
SEC. 112. COLLECTION
OF STANDARDIZED DATA.
(a) IN GENERAL- A group
health plan and a health insurance issuer that offers health insurance coverage
shall collect uniform quality data that include a minimum uniform data set described
in subsection (b).
(b) MINIMUM UNIFORM DATA
SET- The Secretary shall specify (and may from time to time update) the data
required to be included in the minimum uniform data set under subsection (a)
and the standard format for such data. Such data shall include at least--
(1) aggregate utilization
data;
(2) data on the demographic
characteristics of participants, beneficiaries, and enrollees;
(3) data on disease-specific
and age-specific mortality rates and (to the extent feasible) morbidity rates
of such individuals;
(4) data on satisfaction
of such individuals, including data on voluntary disenrollment and grievances;
and
(5) data on quality
indicators and health outcomes, including, to the extent feasible and appropriate,
data on pediatric cases and on a gender-specific basis.
(c) AVAILABILITY- A summary
of the data collected under subsection (a) shall be disclosed under section
121(b)(9). The Secretary shall be provided access to all the data so collected.
(d) VARIATION PERMITTED-
The Secretary may provide for variations in the application of the requirements
of this section to group health plans and health insurance issuers based upon
differences in the delivery system among such plans and issuers as the Secretary
deems appropriate.
SEC. 113. PROCESS FOR
SELECTION OF PROVIDERS.
(a) IN GENERAL- A group
health plan and a health insurance issuer that offers health insurance coverage
shall, if it provides benefits through participating health care professionals,
have a written process for the selection of participating health care professionals,
including minimum professional requirements.
(b) VERIFICATION OF BACKGROUND-
Such process shall include verification of a health care provider's license
and a history of suspension or revocation.
(c) RESTRICTION- Such
process shall not use a high-risk patient base or location of a provider in
an area with residents with poorer health status as a basis for excluding providers
from participation.
(d) NONDISCRIMINATION
BASED ON LICENSURE-
(1) IN GENERAL- Such
process shall not discriminate with respect to participation or indemnification
as to any provider who is acting within the scope of the provider's license
or certification under applicable State law, solely on the basis of such license
or certification.
(2) CONSTRUCTION- Paragraph
(1) shall not be construed--
(A) as requiring
the coverage under a plan or coverage of particular benefits or services
or to prohibit a plan or issuer from including providers only to the extent
necessary to meet the needs of the plan's or issuer's participants, beneficiaries,
or enrollees or from establishing any measure designed to maintain quality
and control costs consistent with the responsibilities of the plan or issuer;
or
(B) to override any
State licensure or scope-of-practice law.
(e) GENERAL NONDISCRIMINATION-
(1) IN GENERAL- Subject
to paragraph (2), such process shall not discriminate with respect to selection
of a health care professional to be a participating health care provider,
or with respect to the terms and conditions of such participation, based on
the professional's race, color, religion, sex, national origin, age, sexual
orientation, or disability (consistent with the Americans with Disabilities
Act of 1990).
(2) RULES- The appropriate
Secretary may establish such definitions, rules, and exceptions as may be
appropriate to carry out paragraph (1), taking into account comparable definitions,
rules, and exceptions in effect under employment-based nondiscrimination laws
and regulations that relate to each of the particular bases for discrimination
described in such paragraph.
SEC. 114. DRUG UTILIZATION
PROGRAM.
A group health plan,
and a health insurance issuer that provides health insurance coverage, that
includes benefits for prescription drugs shall establish and maintain, as part
of its internal quality assurance and continuous quality improvement program
under section 111, a drug utilization program which--
(1) encourages appropriate
use of prescription drugs by participants, beneficiaries, and enrollees and
providers, and
(2) takes appropriate
action to reduce the incidence of improper drug use and adverse drug reactions
and interactions.
SEC. 115. STANDARDS
FOR UTILIZATION REVIEW ACTIVITIES.
(a) COMPLIANCE WITH REQUIREMENTS-
(1) IN GENERAL- A group
health plan, and a health insurance issuer that provides health insurance
coverage, shall conduct utilization review activities in connection with the
provision of benefits under such plan or coverage only in accordance with
a utilization review program that meets the requirements of this section.
(2) USE OF OUTSIDE
AGENTS- Nothing in this section shall be construed as preventing a group health
plan or health insurance issuer from arranging through a contract or otherwise
for persons or entities to conduct utilization review activities on behalf
of the plan or issuer, so long as such activities are conducted in accordance
with a utilization review program that meets the requirements of this section.
(3) UTILIZATION REVIEW
DEFINED- For purposes of this section, the terms `utilization review' and
`utilization review activities' mean procedures used to monitor or evaluate
the clinical necessity, appropriateness, efficacy, or efficiency of health
care services, procedures or settings, and includes prospective review, concurrent
review, second opinions, case management, discharge planning, or retrospective
review.
(b) WRITTEN POLICIES
AND CRITERIA-
(1) WRITTEN POLICIES-
A utilization review program shall be conducted consistent with written policies
and procedures that govern all aspects of the program.
(2) USE OF WRITTEN
CRITERIA-
(A) IN GENERAL- Such
a program shall utilize written clinical review criteria developed pursuant
to the program with the input of appropriate physicians. Such criteria shall
include written clinical review criteria described in section 111(b)(4)(B).
(B) CONTINUING USE
OF STANDARDS IN RETROSPECTIVE REVIEW- If a health care service has been
specifically pre-authorized or approved for an enrollee under such a program,
the program shall not, pursuant to retrospective review, revise or modify
the specific standards, criteria, or procedures used for the utilization
review for procedures, treatment, and services delivered to the enrollee
during the same course of treatment.
(c) CONDUCT OF PROGRAM
ACTIVITIES-
(1) ADMINISTRATION
BY HEALTH CARE PROFESSIONALS- A utilization review program shall be administered
by qualified health care professionals who shall oversee review decisions.
In this subsection, the term `health care professional' means a physician
or other health care practitioner licensed, accredited, or certified to perform
specified health services consistent with State law.
(2) USE OF QUALIFIED,
INDEPENDENT PERSONNEL-
(A) IN GENERAL- A
utilization review program shall provide for the conduct of utilization
review activities only through personnel who are qualified and, to the extent
required, who have received appropriate training in the conduct of such
activities under the program.
(B) PEER REVIEW OF
SAMPLE OF ADVERSE CLINICAL DETERMINATIONS- Such a program shall provide
that clinical peers (as defined in section 191(c)(2)) shall evaluate the
clinical appropriateness of at least a sample of adverse clinical determinations.
(C) PROHIBITION OF
CONTINGENT COMPENSATION ARRANGEMENTS- Such a program shall not, with respect
to utilization review activities, permit or provide compensation or anything
of value to its employees, agents, or contractors in a manner that--
(i) provides incentives,
direct or indirect, for such persons to make inappropriate review decisions,
or
(ii) is based,
directly or indirectly, on the quantity or type of adverse determinations
rendered.
(D) PROHIBITION OF
CONFLICTS- Such a program shall not permit a health care professional who
provides health care services to an individual to perform utilization review
activities in connection with the health care services being provided to
the individual.
(3) ACCESSIBILITY OF
REVIEW- Such a program shall provide that appropriate personnel performing
utilization review activities under the program are reasonably accessible
by toll-free telephone during normal business hours to discuss patient care
and allow response to telephone requests, and that appropriate provision is
made to receive and respond promptly to calls received during other hours.
(4) LIMITS ON FREQUENCY-
Such a program shall not provide for the performance of utilization
review activities with
respect to a class of services furnished to an individual more frequently than
is reasonably required to assess whether the services under review are medically
necessary or appropriate.
(5) LIMITATION ON INFORMATION
REQUESTS- Under such a program, information shall be required to be provided
by health care providers only to the extent it is necessary to perform the
utilization review activity involved.
(6) REVIEW OF PRELIMINARY
UTILIZATION REVIEW DECISION- Under such program a participant, beneficiary,
or enrollee or any provider acting on behalf of such an individual with the
individual's consent, who is dissatisfied with a preliminary utilization review
decision has the opportunity to discuss the decision with, and have such decision
reviewed by, the medical director of the plan or issuer involved (or the director's
designee) who has the authority to reverse the decision.
(d) DEADLINE FOR DETERMINATIONS-
(1) PRIOR AUTHORIZATION
SERVICES- Except as provided in paragraph (2), in the case of a utilization
review activity involving the prior authorization of health care items and
services for an individual, the utilization review program shall make a determination
concerning such authorization, and provide notice of the determination to
the individual or the individual's designee and the individual's health care
provider by telephone and in printed form, as soon as possible in accordance
with the medical exigencies of the cases, and in no event later than 3 business
days after the date of receipt of information that is reasonably necessary
to make such determination.
(2) CONTINUED CARE-
In the case of a utilization review activity involving authorization for continued
or extended health care services for an individual, or additional services
for an individual undergoing a course of continued treatment prescribed by
a health care provider, the utilization review program shall make a determination
concerning such authorization, and provide notice of the determination to
the individual or the individual's designee and the individual's health care
provider by telephone and in printed form, as soon as possible in accordance
with the medical exigencies of the cases, and in no event later than 1 business
day after the date of receipt of information that is reasonably necessary
to make such determination. Such notice shall include, with respect to continued
or extended health care services, the number of extended services approved,
the new total of approved services, the date of onset of services, and the
next review date, if any.
(3) PREVIOUSLY PROVIDED
SERVICES- In the case of a utilization review activity involving retrospective
review of health care services previously provided for an individual, the
utilization review program shall make a determination concerning such services,
and provide notice of the determination to the individual or the individual's
designee and the individual's health care provider by telephone and in printed
form, within 30 days of the date of receipt of information that is reasonably
necessary to make such determination.
(4) REFERENCE TO SPECIAL
RULES FOR EMERGENCY SERVICES, MAINTENANCE CARE, AND POST-STABILIZATION CARE-
For waiver of prior authorization requirements in certain cases involving
emergency services and maintenance care and post-stabilization care, see subsections
(a)(1) and (b) of section 101, respectively.
(e) NOTICE OF ADVERSE
DETERMINATIONS-
(1) IN GENERAL- Notice
of an adverse determination under a utilization review program shall be provided
in printed form and shall include--
(A) the reasons for
the determination (including the clinical rationale);
(B) instructions
on how to initiate an appeal under section 132; and
(C) notice of the
availability, upon request of the individual (or the individual's designee)
of the clinical review criteria relied upon to make such determination.
(2) SPECIFICATION OF
ANY ADDITIONAL INFORMATION- Such a notice shall also specify what (if any)
additional necessary information must be provided to, or obtained by, the
person making the determination in order to make a decision on such an appeal.
SEC. 116. HEALTH CARE
QUALITY ADVISORY BOARD.
(a) ESTABLISHMENT- The
President shall establish an advisory board to provide information to Congress
and the administration on issues relating to quality monitoring and improvement
in the health care provided under group health plans and health insurance coverage.
(b) NUMBER AND APPOINTMENT-
The advisory board shall be composed of the Secretary of Health and Human Services
(or the Secretary's designee), the Secretary of Labor (or the Secretary's designee),
and 20 additional members appointed by the President, in consultation with the
Majority and Minority Leaders of the Senate and House of Representatives. The
members so appointed shall include individuals with expertise in--
(2) education and training
of health professionals;
(3) health care services;
(4) health plan management;
(5) health care accreditation,
quality assurance, improvement, measurement, and oversight;
(6) medical practice,
including practicing physicians;
(7) prevention and
public health; and
(8) public and private
group purchasing for small and large employers or groups.
(c) DUTIES- The advisory
board shall--
(1) identify, update,
and disseminate measures of health care quality for group health plans and
health insurance issuers, including network and non-network plans;
(2) advise the Secretary
on the development and maintenance of the minimum data set in section 112(b);
and
(3) advise the Secretary
on standardized formats for information on group health plans and health insurance
coverage.
The measures identified
under paragraph (1) may be used on a voluntary basis by such plans and issuers.
In carrying out paragraph (1), the advisory board shall consult and cooperate
with national health care standard setting bodies which define quality indicators,
the Agency for Health Care Policy and Research, the Institute of Medicine, and
other public and private entities that have expertise in health care quality.
(d) REPORT- The advisory
board shall provide an annual report to Congress and the President on the quality
of the health care in the United States and national and regional trends in
health care quality. Such report shall include a description of determinants
of health care quality and measurements of practice and quality variability
within the United States.
(e) SECRETARIAL CONSULTATION-
In serving on the advisory board, the Secretaries of Health and Human Services
and Labor (or their designees) shall consult with the Secretaries responsible
for other Federal health insurance and health care programs.
(f) VACANCIES- Any vacancy
on the board shall be filled in such manner as the original appointment. Members
of the board shall serve without compensation but shall be reimbursed for travel,
subsistence, and other necessary expenses incurred by them in the performance
of their duties. Administrative support, scientific support, and technical assistance
for the advisory board shall be provided by the Secretary of Health and Human
Services.
(g) CONTINUATION- Section
14(a)(2)(B) of the Federal Advisory Committee Act (5 U.S.C. App.; relating to
the termination of advisory committees) shall not apply to the advisory board.
Subtitle C--Patient
Information
SEC. 121. PATIENT INFORMATION.
(a) DISCLOSURE REQUIREMENT-
(1) GROUP HEALTH PLANS-
A group health plan shall--
(A) provide to participants
and beneficiaries at the time of initial coverage under the plan (or the
effective date of this section, in the case of individuals who are participants
or beneficiaries as of such date), and at least annually thereafter, the
information described in subsection (b) in printed form;
(B) provide to participants
and beneficiaries, within a reasonable period (as specified by the appropriate
Secretary) before or after the date of significant changes in the information
described in subsection (b), information in printed form on such significant
changes; and
(C) upon request,
make available to participants and beneficiaries, the applicable authority,
and prospective participants and beneficiaries, the information described
in subsection (b) or (c) in printed form.
(2) HEALTH INSURANCE
ISSUERS- A health insurance issuer in connection with the provision of health
insurance coverage shall--
(A) provide to individuals
enrolled under such coverage at the time of enrollment, and at least annually
thereafter, the information described in subsection (b) in printed form;
(B) provide to enrollees,
within a reasonable period (as specified by the appropriate Secretary) before
or after the date of significant changes in the information described in
subsection (b), information in printed form on such significant changes;
and
(C) upon request,
make available to the applicable authority, to individuals who are prospective
enrollees, and to the public the information described in subsection (b)
or (c) in printed form.
(b) INFORMATION PROVIDED-
The information described in this subsection with respect to a group health
plan or health insurance coverage offered by a health insurance issuer includes
the following:
(1) SERVICE AREA- The
service area of the plan or issuer.
(2) BENEFITS- Benefits
offered under the plan or coverage, including--
(A) covered benefits,
including benefit limits and coverage exclusions;
(B) cost sharing,
such as deductibles, coinsurance, and copayment amounts, including any liability
for balance billing, any maximum limitations on out of pocket expenses,
and the maximum out of pocket costs for services that are provided by non
participating providers or that are furnished without meeting the applicable
utilization review requirements;
(C) the extent to
which benefits may be obtained from nonparticipating providers;
(D) the extent to
which a participant, beneficiary, or enrollee may select from among participating
providers and the types of providers participating in the plan or issuer
network;
(E) process for determining
experimental coverage; and
(F) use of a prescription
drug formulary.
(3) ACCESS- A description
of the following:
(A) The number, mix,
and distribution of providers under the plan or coverage.
(B) Out-of-network
coverage (if any) provided by the plan or coverage.
(C) Any point-of-service
option (including any supplemental premium or cost-sharing for such option).
(D) The procedures
for participants, beneficiaries, and enrollees to select, access, and change
participating primary and specialty providers.
(E) The rights and
procedures for obtaining referrals (including standing referrals) to participating
and nonparticipating providers.
(F) The name, address,
and telephone number of participating health care providers and an indication
of whether each such provider is available to accept new patients.
(G) Any limitations
imposed on the selection of qualifying participating health care providers,
including any limitations imposed under section 103(b)(2).
(H) How the plan
or issuer addresses the needs of participants, beneficiaries, and enrollees
and others who do not speak English or who have other special communications
needs in accessing providers under the plan or coverage, including the provision
of information described in this subsection and subsection (c) to such individuals
and including the provision of information in a language other than English
if 5 percent of the number of participants, beneficiaries, and enrollees
communicate in that language instead of English.
(4) OUT-OF-AREA COVERAGE-
Out-of-area coverage provided by the plan or issuer.
(5) EMERGENCY COVERAGE-
Coverage of emergency services, including--
(A) the appropriate
use of emergency services, including use of the 911 telephone system or
its local equivalent in emergency situations and an explanation of what
constitutes an emergency situation;
(B) the process and
procedures of the plan or issuer for obtaining emergency services; and
(C) the locations
of (i) emergency departments, and (ii) other settings, in which plan physicians
and hospitals provide emergency services and post-stabilization care.
(6) PERCENTAGE OF PREMIUMS
USED FOR BENEFITS (LOSS-RATIOS)- In the case of health insurance coverage
only (and not with respect to group health plans that do not provide coverage
through health insurance coverage), a description of the overall loss-ratio
for the coverage (as defined in accordance with rules established or recognized
by the Secretary of Health and Human Services).
(7) PRIOR AUTHORIZATION
RULES- Rules regarding prior authorization or other review requirements that
could result in noncoverage or nonpayment.
(8) GRIEVANCE AND APPEALS
PROCEDURES- All appeal or grievance rights and procedures under the plan or
coverage, including the method for filing grievances and the time frames and
circumstances for acting on grievances and appeals, who is the applicable
authority with respect to the plan or issuer, and the availability of assistance
through an ombudsman to individuals in relation to group health plans and
health insurance coverage.
(9) QUALITY ASSURANCE-
A summary description of the data on quality collected under section 112(a),
including a summary description of the data on satisfaction of participants,
beneficiaries, and enrollees (including data on individual voluntary disenrollment
and grievances and appeals) described in section 112(b)(4).
(10) SUMMARY OF PROVIDER
FINANCIAL INCENTIVES- A summary description of the information on the types
of financial payment incentives (described in section 1852(j)(4) of the Social
Security Act) provided by the plan or issuer under the coverage.
(11) INFORMATION ON
ISSUER- Notice of appropriate mailing addresses and telephone numbers to be
used by participants, beneficiaries, and enrollees in seeking information
or authorization for treatment.
(12) AVAILABILITY OF
INFORMATION ON REQUEST- Notice that the information described in subsection
(c) is available upon request.
(c) INFORMATION MADE
AVAILABLE UPON REQUEST- The information described in this subsection is the
following:
(1) UTILIZATION REVIEW
ACTIVITIES- A description of procedures used and requirements (including circumstances,
time frames, and appeal rights) under any utilization review program under
section 115, including under any drug formulary program under section 107.
(2) GRIEVANCE AND APPEALS
INFORMATION- Information on the number of grievances and appeals and on the
disposition in the aggregate of such matters.
(3) METHOD OF PHYSICIAN
COMPENSATION- An overall summary description as to the method of compensation
of participating physicians, including information on the types of financial
payment incentives (described in section 1852(j)(4) of the Social Security
Act) provided by the plan or issuer under the coverage.
(4) SPECIFIC INFORMATION
ON CREDENTIALS OF PARTICIPATING PROVIDERS- In the case of each participating
provider, a description of the credentials of the provider.
(5) CONFIDENTIALITY
POLICIES AND PROCEDURES- A description of the policies and procedures established
to carry out section 122.
(6) FORMULARY RESTRICTIONS-
A description of the nature of any drug formula restrictions.
(7) PARTICIPATING PROVIDER
LIST- A list of current participating health care providers.
(1) UNIFORMITY- Information
required to be disclosed under this section shall be provided in accordance
with uniform, national reporting standards specified by the Secretary, after
consultation with applicable State authorities, so that prospective enrollees
may compare the attributes of different issuers and coverage offered within
an area.
(2) INFORMATION INTO
HANDBOOK- Nothing in this section shall be construed as preventing a group
health plan or health insurance issuer from making the information under subsections
(b) and (c) available to participants, beneficiaries, and enrollees through
an enrollee handbook or similar publication.
(3) UPDATING PARTICIPATING
PROVIDER INFORMATION- The information on participating health care providers
described in subsection (b)(3)(C) shall be updated within such reasonable
period as determined appropriate by the Secretary. Nothing in this section
shall prevent an issuer from changing or updating other information made available
under this section.
(e) CONSTRUCTION- Nothing
in this section shall be construed as requiring public disclosure of individual
contracts or financial arrangements between a group health plan or health insurance
issuer and any provider.
SEC. 122. PROTECTION
OF PATIENT CONFIDENTIALITY.
Insofar as a group health
plan, or a health insurance issuer that offers health insurance coverage, maintains
medical records or other health information regarding participants, beneficiaries,
and enrollees, the plan or issuer shall establish procedures--
(1) to safeguard the
privacy of any individually identifiable enrollee information;
(2) to maintain such
records and information in a manner that is accurate and timely, and
(3) to assure timely
access of such individuals to such records and information.
SEC. 123. HEALTH INSURANCE
OMBUDSMEN.
(a) IN GENERAL- Each
State that obtains a grant under subsection (c) shall provide for creation and
operation of a Health Insurance Ombudsman through a contract with a not-for-profit
organization that operates independent of group health plans and health insurance
issuers. Such Ombudsman shall be responsible for at least the following:
(1) To assist consumers
in the State in choosing among health insurance coverage or among coverage
options offered within group health plans.
(2) To provide counseling
and assistance to enrollees dissatisfied with their treatment by health insurance
issuers and group health plans in regard to such coverage or plans and with
respect to grievances and appeals regarding determinations under such coverage
or plans.
(b) FEDERAL ROLE- In
the case of any State that does not provide for such an Ombudsman under subsection
(a), the Secretary shall provide for the creation and operation of a Health
Insurance Ombudsman through a contract with a not-for-profit organization that
operates independent of group health plans and health insurance issuers and
that is responsible for carrying out with respect to that State the functions
otherwise provided under subsection (a) by a Health Insurance Ombudsman.
(c) AUTHORIZATION OF
APPROPRIATIONS- There are authorized to be appropriated to the Secretary of
Health and Human Services such amounts as may be necessary to provide for grants
to States for contracts for Health Insurance Ombudsmen under subsection (a)
or contracts for such Ombudsmen under subsection (b).
(d) CONSTRUCTION- Nothing
in this section shall be construed to prevent the use of other forms of enrollee
assistance.
Subtitle D--Grievance
and Appeals Procedures
SEC. 131. ESTABLISHMENT
OF GRIEVANCE PROCESS.
(a) ESTABLISHMENT OF
GRIEVANCE SYSTEM-
(1) IN GENERAL- A group
health plan, and a health insurance issuer in connection with the provision
of health insurance coverage, shall establish and maintain a system to provide
for the presentation and resolution of oral and written grievances brought
by individuals who are participants, beneficiaries, or enrollees, or health
care providers or other individuals acting on behalf of an individual and
with the individual's consent, regarding any aspect of the plan's or issuer's
services.
(2) SCOPE- The system
shall include grievances regarding access to and availability of services,
quality of care, choice and accessibility of providers, network adequacy,
and compliance with the requirements of this title.
(b) GRIEVANCE SYSTEM-
Such system shall include the following components with respect to individuals
who are participants, beneficiaries, or enrollees:
(1) Written notification
to all such individuals and providers of the telephone numbers and business
addresses of the plan or issuer personnel responsible for resolution of grievances
and appeals.
(2) A system to record
and document, over a period of at least 3 previous years, all grievances and
appeals made and their status.
(3) A process providing
for timely processing and resolution of grievances.
(4) Procedures for
follow-up action, including the methods to inform the person making the grievance
of the resolution of the grievance.
(5) Notification to
the continuous quality improvement program under section 111(a) of all grievances
and appeals relating to quality of care.
SEC. 132. INTERNAL APPEALS
OF ADVERSE DETERMINATIONS.
(1) IN GENERAL- A participant
or beneficiary in a group health plan, and an enrollee in health insurance
coverage offered by a health insurance issuer, and any provider or other person
acting on behalf of such an individual with the individual's consent, may
appeal any appealable decision (as defined in paragraph (2)) under the procedures
described in this section and (to the extent applicable) section 133. Such
individuals and providers shall be provided with a written explanation of
the appeal process and the determination upon the conclusion of the appeals
process and as provided in section 121(b)(8).
(2) APPEALABLE DECISION
DEFINED- In this section, the term `appealable decision' means any of the
following:
(A) Denial, reduction,
or termination of, or failure to provide or make payment (in whole or in
part) for, a benefit, including a failure to cover an item or service for
which benefits are otherwise provided because it is determined to be experimental
or investigational or not medically necessary or appropriate.
(B) Failure to provide
coverage of emergency services or reimbursement of maintenance care or post-stabilization
care under section 101.
(C) Failure to provide
a choice of provider under section 103.
(D) Failure to provide
qualified health care providers under section 103.
(E) Failure to provide
access to specialty and other care under section 104.
(F) Failure to provide
continuation of care under section 105.
(G) Failure to provide
coverage of routine patient costs in connection with an approval clinical
trial under section 106.
(H) Failure to provide
access to needed drugs under section 107(a)(3) or 107(b).
(I) Discrimination
in delivery of services in violation of section 109.
(J) An adverse determination
under a utilization review program under section 115.
(K) The imposition
of a limitation that is prohibited under section 151.
(b) INTERNAL APPEAL PROCESS-
(1) IN GENERAL- Each
group health plan and health insurance issuer shall establish and maintain
an internal appeal process under which any participant, beneficiary, enrollee,
or provider acting on behalf of such an individual with the individual's consent,
who is dissatisfied with any appealable decision has the opportunity to appeal
the decision through an internal appeal process. The appeal may be communicated
orally.
(A) IN GENERAL- The
process shall include a review of the decision by a physician or other health
care professional (or professionals) who has been selected by the plan or
issuer and who has not been involved in the appealable decision at issue
in the appeal.
(B) AVAILABILITY
AND PARTICIPATION OF CLINICAL PEERS- The individuals conducting such review
shall include one or more clinical peers (as defined in section 191(c)(2))
who have not been involved in the appealable decision at issue in the appeal.
(A) IN GENERAL- Subject
to subsection (c), the plan or issuer shall conclude each appeal as soon
as possible after the time of the receipt of the appeal in accordance with
medical exigencies of the case involved, but in no event later than--
(i) 72 hours after
the time of receipt of an expedited appeal, and
(ii) except as
provided in subparagraph (B), 15 business days after such time in the
case of all other appeals.
(B) EXTENSION- A
group health plan or health insurance issuer may extend the deadline for
an appeal that does not relate to a decision regarding an expedited appeal
and that does not involve medical exigencies up to an additional 10 business
days where it can demonstrate to the applicable authority reasonable cause
for the delay beyond its control and where it provides, within the original
deadline under subparagraph (A), a written progress report and explanation
for the delay to such authority and to the participant, beneficiary, or
enrollee and provider involved.
(4) NOTICE- If a plan
or issuer denies an appeal, the plan or issuer shall provide the participant,
beneficiary, or enrollee and provider involved with notice in printed form
of the denial and the reasons therefore, together with a notice in printed
form of rights to any further appeal.
(c) EXPEDITED REVIEW
PROCESS-
(1) IN GENERAL- A group
health plan, and a health insurance issuer, shall establish procedures in
writing for the expedited consideration of appeals under subsection (b) in
situations in which the application of the normal timeframe for making a determination
could seriously jeopardize the life or health of the participant, beneficiary,
or enrollee or such an individual's ability to regain maximum function.
(2) PROCESS- Under
such procedures--
(A) the request for
expedited appeal may be submitted orally or in writing by an individual
or provider who is otherwise entitled to request the appeal;
(B) all necessary
information, including the plan's or issuer's decision, shall be transmitted
between the plan or issuer and the requester by telephone, facsimile, or
other similarly expeditious available method; and
(C) the plan or issuer
shall expedite the appeal if the request for an expedited appeal is submitted
under subparagraph (A) by a physician and the request indicates that the
situation described in paragraph (1) exists.
(d) DIRECT USE OF FURTHER
APPEALS- In the event that the plan or issuer fails to comply with any of the
deadlines for completion of appeals under this section or in the event that
the plan or issuer for any reason expressly waives its rights to an internal
review of an appeal under subsection (b), the participant, beneficiary, or enrollee
involved and the provider involved shall be relieved of any obligation to complete
the appeal involved and may, at such an individual's or provider's option, proceed
directly to seek further appeal through any applicable external appeals process.
SEC. 133. EXTERNAL APPEALS
OF ADVERSE DETERMINATIONS.
(a) RIGHT TO EXTERNAL
APPEAL-
(1) IN GENERAL- A group
health plan, and a health insurance issuer offering group health insurance
coverage, shall provide for an external appeals process that meets the requirements
of this section in the case of an externally appealable decision described
in paragraph (2). The appropriate Secretary shall establish standards to carry
out such requirements.
(2) EXTERNALLY APPEALABLE
DECISION DEFINED- For purposes of this section, the term `externally appealable
decision' means an appealable decision (as defined in section 132(a)(2)) if--
(A) the amount involved
exceeds a significant threshold; or
(B) the patient's
life or health is jeopardized as a consequence of the decision.
Such term does not
include a denial of coverage for services that are specifically listed in
plan or coverage documents as excluded from coverage.
(3) EXHAUSTION OF INTERNAL
APPEALS PROCESS- A plan or issuer may condition the use of an external appeal
process in the case of an externally appealable decision upon completion of
the internal review process provided under section 132, but only if the decision
is made in a timely basis consistent with the deadlines provided under this
subtitle.
(b) GENERAL ELEMENTS
OF EXTERNAL APPEALS PROCESS-
(1) CONTRACT WITH QUALIFIED
EXTERNAL APPEAL ENTITY-
(A) CONTRACT REQUIREMENT-
Subject to subparagraph (B), the external appeal process under this section
of a plan or issuer shall be conducted under a contract between the plan
or issuer and one or more qualified external appeal entities (as defined
in subsection (c)).
(B) RESTRICTIONS
ON QUALIFIED EXTERNAL APPEAL ENTITY-
(i) BY STATE FOR
HEALTH INSURANCE ISSUERS- With respect to health insurance issuers in
a State, the State may provide for external review activities to be conducted
by a qualified external appeal entity that is designated by the State
or that is selected by the State in such a manner as to assure an unbiased
determination.
(ii) BY FEDERAL
GOVERNMENT FOR GROUP HEALTH PLANS- With respect to group health plans,
the appropriate Secretary may exercise the same authority as a State may
exercise with respect to health insurance issuers under clause (i). Such
authority may include requiring the use of the qualified external appeal
entity designated or selected under such clause.
(iii) LIMITATION
ON PLAN OR ISSUER SELECTION- If an applicable authority permits more than
one entity to qualify as a qualified external appeal entity with respect
to a group health plan or health insurance issuer and the plan or issuer
may select among such qualified entities, the applicable authority--
(I) shall assure
that the selection process will not create any incentives for external
appeal entities to make a decision in a biased manner, and
(II) shall implement
a procedures for auditing a sample of decisions by such entities to
assure that no such decisions are made in a biased manner.
(C) OTHER TERMS AND
CONDITIONS- The terms and conditions of a contract under this paragraph
shall be consistent with the standards the appropriate Secretary shall establish
to assure there is no real or apparent conflict of interest in the conduct
of external appeal activities. Such contract shall provide that the direct
costs of the process (not including costs of representation of a participant,
beneficiary, or enrollee) shall be paid by the plan or issuer, and not by
the participant, beneficiary, or enrollee.
(2) ELEMENTS OF PROCESS-
An external appeal process shall be conducted consistent with standards established
by the appropriate Secretary that include at least the following:
(A) FAIR PROCESS;
DE NOVO DETERMINATION- The process shall provide for a fair, de novo determination.
(B) DETERMINATION
CONCERNING EXTERNALLY APPEALABLE DECISIONS- A qualified external appeal
entity shall determine whether a decision is an externally appealable decision
and related decisions, including--
(i) whether such
a decision involves an expedited appeal;
(ii) the appropriate
deadlines for internal review process required due to medical exigencies
in a case; and
(iii) whether such
a process has been completed.
(C) OPPORTUNITY TO
SUBMIT EVIDENCE, HAVE REPRESENTATION, AND MAKE ORAL PRESENTATION- Each party
to an externally appealable decision--
(i) may submit
and review evidence related to the issues in dispute,
(ii) may use the
assistance or representation of one or more individuals (any of whom may
be an attorney), and
(iii) may make
an oral presentation.
(D) PROVISION OF
INFORMATION- The plan or issuer involved shall provide timely access to
all its records relating to the matter of the externally appealable decision
and to all provisions of the plan or health insurance coverage (including
any coverage manual) relating to the matter.
(E) TIMELY DECISIONS-
A determination by the external appeal entity on the decision shall--
(i) be made orally
or in writing and, if it is made orally, shall be supplied to the parties
in writing as soon as possible;
(ii) be binding
on the plan or issuer;
(iii) be made in
accordance with the medical exigencies of the case involved, but in no
event later than 60 days (or 72 hours in the case of an expedited appeal)
from the date of completion of the filing of notice of external appeal
of the decision;
(iv) state, in
layperson's language, the basis for the determination, including, if relevant,
any basis in the terms or conditions of the plan or coverage; and
(v) inform the
participant, beneficiary, or enrollee of the individual's rights to seek
further review by the courts (or other process) of the external appeal
determination.
(c) QUALIFICATIONS OF
EXTERNAL APPEAL ENTITIES-
(1) IN GENERAL- For
purposes of this section, the term `qualified external appeal entity' means,
in relation to a plan or issuer, an entity (which may be a governmental entity)
that is certified under paragraph (2) as meeting the following requirements:
(A) There is no real
or apparent conflict of interest that would impede the entity conducting
external appeal activities independent of the plan or issuer.
(B) The entity conducts
external appeal activities through clinical peers.
(C) The entity has
sufficient medical, legal, and other expertise and sufficient staffing to
conduct external appeal activities for the plan or issuer on a timely basis
consistent with subsection (b)(3)(E).
(D) The entity meets
such other requirements as the appropriate Secretary may impose.
(2) CERTIFICATION OF
EXTERNAL APPEAL ENTITIES-
(A) IN GENERAL- In
order to be treated as a qualified external appeal entity with respect to--
(i) a group health
plan, the entity must be certified (and, in accordance with subparagraph
(B), periodically recertified) as meeting the requirements of paragraph
(1) by the Secretary of Labor (or under a process recognized or approved
by the Secretary of Labor); or
(ii) a health insurance
issuer operating in a State, the entity must be certified (and, in accordance
with subparagraph (B), periodically recertified) as meeting such requirements
by the applicable State authority (or, if the States has not established
an adequate certification and recertification process, by the Secretary
of Health and Human Services, or under a process recognized or approved
by such Secretary).
(B) RECERTIFICATION
PROCESS- The appropriate Secretary shall develop standards for the recertification
of external appeal entities. Such standards shall include a specification
of--
(i) the information
required to be submitted as a condition of recertification on the entity's
performance of external appeal activities, which information shall include
the number of cases reviewed, a summary of the disposition of those cases,
the length of time in making determinations on those cases, and such information
as may be necessary to assure the independence of the entity from the
plans or issuers for which external appeal activities are being conducted;
and
(ii) the periodicity
which recertification will be required.
(d) CONTINUING LEGAL
RIGHTS OF ENROLLEES- Nothing in this title shall be construed as removing any
legal rights of participants, beneficiaries, enrollees, and others under State
or Federal law, including the right to file judicial actions to enforce rights.
Subtitle E--Protecting
the Doctor-Patient Relationship
SEC. 141. PROHIBITION
OF INTERFERENCE WITH CERTAIN MEDICAL COMMUNICATIONS.
(1) GENERAL RULE- The
provisions of any contract or agreement, or the operation of any contract
or agreement, between a group health plan or health insurance issuer in relation
to health insurance coverage (including any partnership, association, or other
organization that enters into or administers such a contract or agreement)
and a health care provider (or group of health care providers) shall not prohibit
or restrict the provider from engaging in medical communications with the
provider's patient.
(2) NULLIFICATION-
Any contract provision or agreement described in paragraph (1) shall be null
and void.
(b) RULES OF CONSTRUCTION-
Nothing in this section shall be construed--
(1) to prohibit the
enforcement, as part of a contract or agreement to which a health care provider
is a party, of any mutually agreed upon terms and conditions, including terms
and conditions requiring a health care provider to participate in, and cooperate
with, all programs, policies, and procedures developed or operated by a group
health plan or health insurance issuer to assure, review, or improve the quality
and effective utilization of health care services (if such utilization is
according to guidelines or protocols that are based on clinical or scientific
evidence and the professional judgment of the provider) but only if the guidelines
or protocols under such utilization do not prohibit or restrict medical communications
between providers and their patients; or
(2) to permit a health
care provider to misrepresent the scope of benefits covered under the group
health plan or health insurance coverage or to otherwise require a group health
plan health insurance issuer to reimburse providers for benefits not covered
under the plan or coverage.
(c) MEDICAL COMMUNICATION
DEFINED- In this section:
(1) IN GENERAL- The
term `medical communication' means any communication made by a health care
provider with a patient of the health care
provider (or the guardian
or legal representative of such patient) with respect to--
(A) the patient's
health status, medical care, or treatment options;
(B) any utilization
review requirements that may affect treatment options for the patient; or
(C) any financial
incentives that may affect the treatment of the patient.
(2) MISREPRESENTATION-
The term `medical communication' does not include a communication by a health
care provider with a patient of the health care provider (or the guardian
or legal representative of such patient) if the communication involves a knowing
or willful misrepresentation by such provider.
SEC. 142. PROHIBITION
AGAINST TRANSFER OF INDEMNIFICATION OR IMPROPER INCENTIVE ARRANGEMENTS.
(a) PROHIBITION OF TRANSFER
OF INDEMNIFICATION-
(1) IN GENERAL- No
contract or agreement between a group health plan or health insurance issuer
(or any agent acting on behalf of such a plan or issuer) and a health care
provider shall contain any provision purporting to transfer to the health
care provider by indemnification or otherwise any liability relating to activities,
actions, or omissions of the plan, issuer, or agent (as opposed to the provider).
(2) NULLIFICATION-
Any contract or agreement provision described in paragraph (1) shall be null
and void.
(b) PROHIBITION OF IMPROPER
PHYSICIAN INCENTIVE PLANS-
(1) IN GENERAL- A group
health plan and a health insurance issuer offering health insurance coverage
may not operate any physician incentive plan (as defined in subparagraph (B)
of section 1876(i)(8) of the Social Security Act) unless the requirements
described in subparagraph (A) of such section are met with respect to such
a plan.
(2) APPLICATION- For
purposes of carrying out paragraph (1), any reference in section 1876(i)(8)
of the Social Security Act to the Secretary, an eligible organization, or
an individual enrolled with the organization shall be treated as a reference
to the applicable authority, a group health plan or health insurance issuer,
respectively, and a participant, beneficiary, or enrollee with the plan or
organization, respectively.
SEC. 143. ADDITIONAL
RULES REGARDING PARTICIPATION OF HEALTH CARE PROFESSIONALS.
(a) PROCEDURES- Insofar
as a group health plan, or health insurance issuer that offers health insurance
coverage, provides benefits through participating health care professionals,
the plan or issuer shall establish reasonable procedures relating to the participation
(under an agreement between a professional and the plan or issuer) of such professionals
under the plan or coverage. Such procedures shall include--
(1) providing notice
of the rules regarding participation;
(2) providing written
notice of participation decisions that are adverse to professionals; and
(3) providing a process
within the plan or issuer for appealing such adverse decisions, including
the presentation of information and views of the professional regarding such
decision.
(b) CONSULTATION IN MEDICAL
POLICIES- A group health plan, and health insurance issuer that offers health
insurance coverage, shall consult with participating physicians (if any) regarding
the plan's or issuer's medical policy, quality, and medical management procedures.
SEC. 144. PROTECTION
FOR PATIENT ADVOCACY.
(a) PROTECTION FOR USE
OF UTILIZATION REVIEW AND GRIEVANCE PROCESS- A group health plan, and a health
insurance issuer with respect to the provision of health insurance coverage,
may not retaliate against a participant, beneficiary, enrollee, or health care
provider based on the participant's, beneficiary's, enrollee's or provider's
use of, or participation in, a utilization review process or a grievance process
of the plan or issuer (including an internal or external review or appeal process)
under this title.
(b) PROTECTION FOR QUALITY
ADVOCACY BY HEALTH CARE PROFESSIONALS-
(1) IN GENERAL- A group
health plan or health insurance issuer may not retaliate or discriminate against
a protected health care professional because the professional in good faith--
(A) discloses information
relating to the care, services, or conditions affecting one or more participants,
beneficiaries, or enrollees of the plan or issuer to an appropriate public
regulatory agency, an appropriate private accreditation body, or appropriate
management personnel of the plan or issuer; or
(B) initiates, cooperates,
or otherwise participates in an investigation or proceeding by
such an agency with respect
to such care, services, or conditions.
If an institutional
health care provider is a participating provider with such a plan or issuer
or otherwise receives payments for benefits provided by such a plan or issuer,
the provisions of the previous sentence shall apply to the provider in relation
to care, services, or conditions affecting one or more patients within an
institutional health care provider in the same manner as they apply to the
plan or issuer in relation to care, services, or conditions provided to one
or more participants, beneficiaries, or enrollees; and for purposes of applying
this sentence, any reference to a plan or issuer is deemed a reference to
the institutional health care provider.
(2) GOOD FAITH ACTION-
For purposes of paragraph (1), a protected health care professional is considered
to be acting in good faith with respect to disclosure of information or participation
if, with respect to the information disclosed as part of the action--
(A) the disclosure
is made on the basis of personal knowledge and is consistent with that degree
of learning and skill ordinarily possessed by health care professionals
with the same licensure or certification and the same experience;
(B) the professional
reasonably believes the information to be true;
(C) the information
evidences either a violation of a law, rule, or regulation, of an applicable
accreditation standard, or of a generally recognized professional or clinical
standard or that a patient is in imminent hazard of loss of life or serious
injury; and
(D) subject to subparagraphs
(B) and (C) of paragraph (3), the professional has followed reasonable internal
procedures of the plan, issuer, or institutional health care provider established
or the purpose of addressing quality concerns before making the disclosure.
(3) EXCEPTION AND SPECIAL
RULE-
(A) GENERAL EXCEPTION-
Paragraph (1) does not protect disclosures that would violate Federal or
State law or diminish or impair the rights of any person to the continued
protection of confidentiality of communications provided by such law.
(B) NOTICE OF INTERNAL
PROCEDURES- Subparagraph (D) of paragraph (2) shall not apply unless the
internal procedures involved are reasonably expected to be known to the
health care professional involved. For purposes of this subparagraph, a
health care professional is reasonably expected to know of internal procedures
if those procedures have been made available to the professional through
distribution or posting.
(C) INTERNAL PROCEDURE
EXCEPTION- Subparagraph (D) of paragraph (2) also shall not apply if--
(i) the disclosure
relates to an imminent hazard of loss of life or serious injury to a patient;
(ii) the disclosure
is made to an appropriate private accreditation body pursuant to disclosure
procedures established by the body; or
(iii) the disclosure
is in response to an inquiry made in an investigation or proceeding of
an appropriate public regulatory agency and the information disclosed
is limited to the scope of the investigation or proceeding.
(4) ADDITIONAL CONSIDERATIONS-
It shall not be a violation of paragraph (1) to take an adverse action against
a protected health care professional if the plan, issuer, or provider taking
the adverse action involved demonstrates that it would have taken the same
adverse action even in the absence of the activities protected under such
paragraph.
(5) NOTICE- A group
health plan, health insurance issuer, and institutional health care provider
shall post a notice, to be provided or approved by the Secretary of Labor,
setting forth excerpts from, or summaries of, the pertinent provisions of
this subsection and information pertaining to enforcement of such provisions.
(A) DETERMINATIONS
OF COVERAGE- Nothing in this subsection shall be construed to prohibit a
plan or issuer from making a determination not to pay for a particular medical
treatment or service or the services of a type of health care professional.
(B) ENFORCEMENT OF
PEER REVIEW PROTOCOLS AND INTERNAL PROCEDURES- Nothing in this subsection
shall be construed to prohibit a plan, issuer, or provider from establishing
and enforcing reasonable peer review or utilization review protocols or
determining whether a protected health care professional has complied with
those protocols or from establishing and enforcing internal procedures for
the purpose of addressing quality concerns.
(C) RELATION TO OTHER
RIGHTS- Nothing in this subsection shall be construed to abridge rights
of participants, beneficiaries, enrollees, and protected health care professionals
under other applicable Federal or State laws.
(7) PROTECTED HEALTH
CARE PROFESSIONAL DEFINED- For purposes of this subsection, the term `protected
health care professional' means an individual who is a licensed or certified
health care professional and who--
(A) with respect
to a group health plan or health insurance issuer, is an employee of the
plan or issuer or has a contract with the plan or issuer for provision of
services for which benefits are available under the plan or issuer; or
(B) with respect
to an institutional health care provider, is an employee of the provider
or has a contract or other arrangement with the
provider respecting the
provision of health care services.
Subtitle F--Promoting
Good Medical Practice
SEC. 151. PROMOTING
GOOD MEDICAL PRACTICE.
(a) PROHIBITING ARBITRARY
LIMITATIONS OR CONDITIONS FOR THE PROVISION OF SERVICES-
(1) IN GENERAL- A group
health plan, and a health insurance issuer in connection with the provision
of health insurance coverage, may not arbitrarily interfere with or alter
the decision of the treating physician regarding the manner or setting in
which particular services are delivered if the services are medically necessary
or appropriate for treatment or diagnosis to the extent that such treatment
or diagnosis is otherwise a covered benefit.
(2) CONSTRUCTION- Paragraph
(1) shall not be construed as prohibiting a plan or issuer from limiting the
delivery of services to one or more health care providers within a network
of such providers.
(b) NO CHANGE IN COVERAGE-
Subsection (a) shall not be construed as requiring coverage of particular services
the coverage of which is otherwise not covered under the terms of the plan or
coverage or from conducting utilization review activities consistent with this
subsection.
(c) MEDICAL NECESSITY
OR APPROPRIATENESS DEFINED- In subsection (a), the term `medically necessary
or appropriate' means, with respect to a service or benefit, a service or benefit
which is consistent with generally accepted principles of professional medical
practice.
SEC. 152. STANDARDS
RELATING TO BENEFITS FOR CERTAIN BREAST CANCER TREATMENT.
(a) REQUIREMENTS FOR
MINIMUM HOSPITAL STAY FOLLOWING MASTECTOMY OR LYMPH NODE DISSECTION-
(1) IN GENERAL- A group
health plan, and a health insurance issuer offering group health insurance
coverage, may not--
(A) except as provided
in paragraph (2)--
(i) restrict benefits
for any hospital length of stay in connection with a mastectomy for the
treatment of breast cancer to less than 48 hours, or
(ii) restrict benefits
for any hospital length of stay in connection with a lymph node dissection
for the treatment of breast cancer to less than 24 hours, or
(B) require that
a provider obtain authorization from the plan or the issuer for prescribing
any length of stay required under subparagraph (A) (without regard to paragraph
(2)).
(2) EXCEPTION- Paragraph
(1)(A) shall not apply in connection with any group health plan or health
insurance issuer in any case in which the decision to discharge the woman
involved prior to the expiration of the minimum length of stay otherwise required
under paragraph (1)(A) is made by the attending provider in consultation with
the woman or in a case involving a partial mastectomy without lymph node dissection.
(b) PROHIBITIONS- A group
health plan, and a health insurance issuer offering group health insurance coverage
in connection with a group health plan, may not--
(1) deny to a woman
eligibility, or continued eligibility, to enroll or to renew coverage under
the terms of the plan, solely for the purpose of avoiding the requirements
of this section;
(2) provide monetary
payments or rebates to women to encourage such women to accept less than the
minimum protections available under this section;
(3) penalize or otherwise
reduce or limit the reimbursement of an attending provider because such provider
provided care to an individual participant or beneficiary in accordance with
this section;
(4) provide incentives
(monetary or otherwise) to an attending provider to induce such provider to
provide care to an individual participant or beneficiary in a manner inconsistent
with this section; or
(5) subject to subsection
(c)(3), restrict benefits for any portion of a period within a hospital length
of stay required under subsection (a) in a manner which is less favorable
than the benefits provided for any preceding portion of such stay.
(c) RULES OF CONSTRUCTION-
(1) Nothing in this
section shall be construed to require a woman who is a participant or beneficiary--
(A) to undergo a
mastectomy or lymph node dissection in a hospital; or
(B) to stay in the
hospital for a fixed period of time following a mastectomy or lymph node
dissection.
(2) This section shall
not apply with respect to any group health plan, or any group health insurance
coverage offered by a health insurance issuer, which does not provide benefits
for hospital lengths of stay in connection with a mastectomy or lymph node
dissection for the treatment of breast cancer.
(3) Nothing in this
section shall be construed as preventing a group health plan or issuer from
imposing deductibles, coinsurance, or other cost-sharing in relation to benefits
for hospital lengths of stay in connection with a mastectomy or lymph node
dissection for the treatment of breast cancer under the plan (or under health
insurance coverage offered in connection with a group health plan), except
that such coinsurance or other cost-sharing for any portion of a period within
a hospital length of stay required under subsection (a) may not be greater
than such coinsurance or cost-sharing for any preceding portion of such stay.
(d) LEVEL AND TYPE OF
REIMBURSEMENTS- Nothing in this section shall be construed to prevent a group
health plan or a health insurance issuer offering group health insurance coverage
from negotiating the level and type of reimbursement with a provider for care
provided in accordance with this section.
(e) EXCEPTION FOR HEALTH
INSURANCE COVERAGE IN CERTAIN STATES-
(1) IN GENERAL- The
requirements of this section shall not apply with respect to health insurance
coverage if there is a State law (as defined in section 2723(d)(1) of the
Public Health Service Act) for a State that regulates such coverage that is
described in any of the following subparagraphs:
(A) Such State law
requires such coverage to provide for at least a 48-hour hospital length
of stay following a mastectomy performed for treatment of breast cancer
and at least a 24-hour hospital length of stay following a lymph node dissection
for treatment of breast cancer.
(B) Such State law
requires, in connection with such coverage for surgical treatment of breast
cancer, that the hospital length of stay for such care is left to the decision
of (or required to be made by) the attending provider in consultation with
the woman involved.
(2) CONSTRUCTION- Section
2723(a)(1) of the Public Health Service Act and section 731(a)(1) of the Employee
Retirement Income Security Act of 1974 shall not be construed as superseding
a State law described in paragraph (1).
SEC. 153. STANDARDS
RELATING TO BENEFITS FOR RECONSTRUCTIVE BREAST SURGERY.
(a) REQUIREMENTS FOR
RECONSTRUCTIVE BREAST SURGERY-
(1) IN GENERAL- A group
health plan, and a health insurance issuer offering group health insurance
coverage, that provides coverage for breast surgery in connection with a mastectomy
shall provide coverage for reconstructive breast surgery resulting from the
mastectomy. Such coverage shall include coverage for all stages of reconstructive
breast surgery performed on a nondiseased breast to establish symmetry with
the diseased when reconstruction on the diseased breast is performed and coverage
of prostheses and complications of mastectomy including lymphedema.
(2) RECONSTRUCTIVE
BREAST SURGERY DEFINED- In this section, the term `reconstructive breast surgery'
means surgery performed as a result of a mastectomy to reestablish symmetry
between two breasts, and includes augmentation mammoplasty, reduction mammoplasty,
and mastopexy.
(3) MASTECTOMY DEFINED-
In this section, the term `mastectomy' means the surgical removal of all or
part of a breast.
(1) DENIAL OF COVERAGE
BASED ON COSMETIC SURGERY- A group health plan, and a health insurance issuer
offering group health insurance coverage in connection with a group health
plan, may not deny coverage described in subsection (a)(1) on the basis that
the coverage is for cosmetic surgery.
(2) APPLICATION OF
SIMILAR PROHIBITIONS- Paragraphs (2) through (5) of section 152 shall apply
under this section in the same manner as they apply with respect to section
152.
(c) RULES OF CONSTRUCTION-
(1) Nothing in this
section shall be construed to require a woman who is a participant or beneficiary
to undergo reconstructive breast surgery.
(2) This section shall
not apply with respect to any group health plan, or any group health insurance
coverage offered by a health insurance issuer, which does not provide benefits
for mastectomies.
(3) Nothing in this
section shall be construed as preventing a group health plan or issuer from
imposing deductibles, coinsurance, or other cost-sharing in relation to benefits
for reconstructive breast surgery under the plan (or under health insurance
coverage offered in connection with a group health plan), except that such
coinsurance or other cost-sharing for any portion may not be greater than
such coinsurance or cost-sharing that is otherwise applicable with respect
to benefits for mastectomies.
(e) LEVEL AND TYPE OF
REIMBURSEMENTS- Nothing in this section shall be construed to prevent a group
health plan or a health insurance issuer offering group health insurance coverage
from negotiating the level and type of reimbursement with a provider for care
provided in accordance with this section.
(f) EXCEPTION FOR HEALTH
INSURANCE COVERAGE IN CERTAIN STATES-
(1) IN GENERAL- The
requirements of this section shall not apply with respect to health insurance
coverage if there is a State law (as defined in section 2723(d)(1) of the
Public Health Service Act) for a State that regulates such coverage and that
requires coverage of at least the coverage of reconstructive breast surgery
otherwise required under this section.
(2) CONSTRUCTION- Section
2723(a)(1) of the Public Health Service Act and section 731(a)(1) of the Employee
Retirement Income Security Act of 1974 shall not be construed as superseding
a State law described in paragraph (1).
Subtitle G--Definitions
SEC. 191. DEFINITIONS.
(a) INCORPORATION OF
GENERAL DEFINITIONS- The provisions of section 2971 of the Public Health Service
Act shall apply for purposes of this title in the same manner as they apply
for purposes of title XXVII of such Act.
(b) SECRETARY- Except
as otherwise provided, the term `Secretary' means the Secretary of Health and
Human Services, in consultation with the Secretary of Labor and the Secretary
of the Treasury and the term `appropriate Secretary' means the Secretary of
Health and Human Services in relation to carrying out this title under sections
2706 and 2751 of the Public Health Service Act, the Secretary of Labor in relation
to carrying out this title under section 713 of the Employee Retirement Income
Security Act of 1974, and the Secretary of the Treasury in relation to carrying
out this title under chapter 100 and section 4980D of the Internal Revenue Code
of 1986.
(c) ADDITIONAL DEFINITIONS-
For purposes of this title:
(1) APPLICABLE AUTHORITY-
The term `applicable authority' means--
(A) in the case of
a group health plan, the Secretary of Health and Human Services and the
Secretary of Labor; and
(B) in the case of
a health insurance issuer with respect to a specific provision of this title,
the applicable State authority (as defined in section 2791(d) of the Public
Health Service Act), or the Secretary of Health and Human Services, if such
Secretary is enforcing such provision under section 2722(a)(2) or 2761(a)(2)
of the Public Health Service Act.
(2) CLINICAL PEER-
The term `clinical peer' means, with respect to a review or appeal, a physician
(allopathic or osteopathic) or other health care professional who holds a
non-restricted license in a State and who is appropriately credentialed in
the same or similar specialty as typically manages the medical condition,
procedure, or treatment under review or appeal and includes a pediatric specialist
where appropriate; except that only a physician may be a clinical peer with
respect to the review or appeal of treatment rendered by a physician.
(3) HEALTH CARE PROVIDER-
The term `health care provider' includes a physician or other health care
professional, as well as an institutional provider of health care services.
(4) NONPARTICIPATING-
The term `nonparticipating' means, with respect to a health care provider
that provides health care items and services to a participant, beneficiary,
or enrollee under group health plan or health insurance coverage, a health
care provider that is not a participating health care provider with respect
to such items and services.
(5) PARTICIPATING-
The term `participating' mean, with respect to a health care provider that
provides health care items and services to a participant, beneficiary, or
enrollee under group health plan or health insurance coverage offered by a
health insurance issuer, a health care provider that furnishes such items
and services under a contract or other arrangement with the plan or issuer.
SEC. 192. PREEMPTION;
STATE FLEXIBILITY; CONSTRUCTION.
(a) CONTINUED APPLICABILITY
OF STATE LAW WITH RESPECT TO HEALTH INSURANCE ISSUERS-
(1) IN GENERAL- Subject
to paragraph (2), this title shall not be construed to supersede any provision
of State law which establishes, implements, or continues in effect any standard
or requirement solely relating to health insurance issuers in connection with
group health insurance coverage except to the extent that such standard or
requirement prevents the application of a requirement of this title.
(2) CONTINUED PREEMPTION
WITH RESPECT TO GROUP HEALTH PLANS- Nothing in this title shall be construed
to affect or modify the provisions of section 514 of the Employee Retirement
Income Security Act of 1974 with respect to group health plans.
(b) RULES OF CONSTRUCTION-
Except as provided in sections 152 and 153, nothing in this title shall be construed
as requiring a group health plan or health insurance coverage to provide specific
benefits under the terms of such plan or coverage.
(c) DEFINITIONS- For
purposes of this section:
(1) STATE LAW- The
term `State law' includes all laws, decisions, rules, regulations, or other
State action having the effect of law, of any State. A law of the United States
applicable only to the District of Columbia shall be treated as a State law
rather than a law of the United States.
(2) STATE- The term
`State' includes a State, the Northern Mariana Islands, any political
subdivisions of a State
or such Islands, or any agency or instrumentality of either.
SEC. 193. REGULATIONS.
The Secretaries of Health
and Human Services, Labor, and the Treasury shall issue such regulations as
may be necessary or appropriate to carry out this title. Such regulations shall
be issued consistent with section 104 of Health Insurance Portability and Accountability
Act of 1996. Such Secretaries may promulgate any interim final rules as the
Secretaries determine are appropriate to carry out this title.
TITLE II--APPLICATION
OF PATIENT PROTECTION STANDARDS TO GROUP HEALTH PLANS AND HEALTH INSURANCE
COVERAGE UNDER PUBLIC HEALTH SERVICE ACT
SEC. 201. APPLICATION
TO GROUP HEALTH PLANS AND GROUP HEALTH INSURANCE COVERAGE.
(a) IN GENERAL- Subpart
2 of part A of title XXVII of the Public Health Service Act is amended by adding
at the end the following new section:
`SEC. 2706. PATIENT
PROTECTION STANDARDS.
`(a) IN GENERAL- Each
group health plan shall comply with patient protection requirements under title
I of the Patients' Bill of Rights Act of 1998, and each health insurance issuer
shall comply with patient protection requirements under such title with respect
to group health insurance coverage it offers, and such requirements shall be
deemed to be incorporated into this subsection.
`(b) NOTICE- A group
health plan shall comply with the notice requirement under section 711(d) of
the Employee Retirement Income Security Act of 1974 with respect to the requirements
referred to in subsection (a) and a health insurance issuer shall comply with
such notice requirement as if such section applied to such issuer and such issuer
were a group health plan.'.
(b) CONFORMING AMENDMENT-
Section 2721(b)(1)(A) of such Act (42 U.S.C. 300gg-21(b)(1)(A)) is amended by
inserting `(other than section 2706)' after `requirements of such subparts'.
SEC. 202. APPLICATION
TO INDIVIDUAL HEALTH INSURANCE COVERAGE.
Part B of title XXVII
of the Public Health Service Act is amended by inserting after section 2751
the following new section:
`SEC. 2752. PATIENT
PROTECTION STANDARDS.
`(a) IN GENERAL- Each
health insurance issuer shall comply with patient protection requirements under
title I of the Patients' Bill of Rights Act of 1998 with respect to individual
health insurance coverage it offers, and such requirements shall be deemed to
be incorporated into this subsection.
`(b) NOTICE- A health
insurance issuer under this part shall comply with the notice requirement under
section 711(d) of the Employee Retirement Income Security Act of 1974 with respect
to the requirements of such title as if such section applied to such issuer
and such issuer were a group health plan.'.
TITLE III--AMENDMENTS
TO THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974
SEC. 301. APPLICATION
OF PATIENT PROTECTION STANDARDS TO GROUP HEALTH PLANS AND GROUP HEALTH INSURANCE
COVERAGE UNDER THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974.
(a) IN GENERAL- Subpart
B of part 7 of subtitle B of title I of the Employee Retirement Income Security
Act of 1974 is amended by adding at the end the following new section:
`SEC. 713. PATIENT PROTECTION
STANDARDS.
`(a) IN GENERAL- Subject
to subsection (b), a group health plan (and a health insurance issuer offering
group health insurance coverage in connection with such a plan) shall comply
with the requirements of title I of the Patients' Bill of Rights Act of 1998
(as in effect as of the date of the enactment of such Act), and such requirements
shall be deemed to be incorporated into this subsection.
`(b) PLAN SATISFACTION
OF CERTAIN REQUIREMENTS-
`(1) SATISFACTION OF
CERTAIN REQUIREMENTS THROUGH INSURANCE- For purposes of subsection (a), insofar
as a group health plan provides benefits in the form of health insurance coverage
through a health insurance issuer, the plan shall be treated as meeting the
following requirements of title I of the Patients' Bill of Rights Act of 1998
with respect to such benefits and not be considered as failing to meet such
requirements because of a failure of the issuer to meet such requirements
so long as the plan sponsor or its representatives did not cause such failure
by the issuer:
`(A) Section 101
(relating to access to emergency care).
`(B) Section 102(a)(1)
(relating to offering option to purchase point-of-service coverage), but
only insofar as the plan is meeting such requirement through an agreement
with the issuer to offer the option to purchase point-of-service coverage
under such section.
`(C) Section 103
(relating to choice of providers).
`(D) Section 104
(relating to access to specialty care).
`(E) Section 105(a)(1)
(relating to continuity in case of termination of provider contract) and
section 105(a)(2) (relating to continuity in case of termination of issuer
contract), but only insofar as a replacement issuer assumes the obligation
for continuity of care.
`(F) Section 106
(relating to coverage for individuals participating in approved clinical
trials.)
`(G) Section 107
(relating to access to needed prescription drugs).
`(H) Section 108
(relating to adequacy of provider network).
`(I) Subtitle B (relating
to quality assurance).
`(J) Section 143
(relating to additional rules regarding participation of health care professionals).
`(K) Section 152
(relating to standards relating to benefits for certain breast cancer treatment).
`(L) Section 153
(relating to standards relating to benefits for reconstructive breast surgery).
`(2) INFORMATION- With
respect to information required to be provided or made available under section
121, in the case of a group health plan that provides benefits in the form
of health insurance coverage through a health insurance issuer, the Secretary
shall determine the circumstances under which the plan is not required to
provide or make available the information (and is not liable for the issuer's
failure to provide or make available the information), if the issuer is obligated
to provide and make available (or provides and makes available) such information.
`(3) GRIEVANCE AND
INTERNAL APPEALS- With respect to the grievance system and internal appeals
process required to be established under sections 131 and 132, in the case
of a group health plan that provides benefits in the form of health insurance
coverage through a health insurance issuer, the Secretary shall determine
the circumstances under which the plan is not required to provide for such
system and process (and is not liable for the issuer's failure to provide
for such system and process), if the issuer is obligated to provide for (and
provides for) such system and process.
`(4) EXTERNAL APPEALS-
Pursuant to rules of the Secretary, insofar as a group health plan enters
into a contract with a qualified external appeal entity for the conduct of
external appeal activities in accordance with section 133, the plan shall
be treated as meeting the requirement of such section and is not liable for
the entity's failure to meet any requirements under such section.
`(5) APPLICATION TO
PROHIBITIONS- Pursuant to rules of the Secretary, if a health insurance issuer
offers health insurance coverage in connection with a group health plan and
takes an action in violation of any of the following sections, the group health
plan shall not be liable for such violation unless the plan caused such violation:
`(A) Section 109
(relating to nondiscrimination in delivery of services).
`(B) Section 141
(relating to prohibition of interference with certain medical communications).
`(C) Section 142
(relating to prohibition against transfer of indemnification or improper
incentive arrangements).
`(D) Section 144
(relating to prohibition on retaliation).
`(E) Section 151
(relating to promoting good medical practice).
`(6) CONSTRUCTION-
Nothing in this subsection shall be construed to affect or modify the responsibilities
of the fiduciaries of a group health plan under part 4 of subtitle B.
`(7) APPLICATION TO
CERTAIN PROHIBITIONS AGAINST RETALIATION- With respect to compliance with
the requirements
of section 144(b)(1)
of the Patients' Bill of Rights Act of 1998, for purposes of this subtitle the
term `group health plan' is deemed to include a reference to an institutional
health care provider.
`(c) ENFORCEMENT OF CERTAIN
REQUIREMENTS-
`(1) COMPLAINTS- Any
protected health care professional who believes that the professional has
been retaliated or discriminated against in violation of section 144(b)(1)
of the Patients' Bill of Rights Act of 1998 may file with the Secretary a
complaint within 180 days of the date of the alleged retaliation or discrimination.
`(2) INVESTIGATION-
The Secretary shall investigate such complaints and shall determine if a violation
of such section has occurred and, if so, shall issue an order to ensure that
the protected health care professional does not suffer any loss of position,
pay, or benefits in relation to the plan, issuer, or provider involved, as
a result of the violation found by the Secretary.
`(d) CONFORMING REGULATIONS-
The Secretary may issue regulations to coordinate the requirements on group
health plans under this section with the requirements imposed under the other
provisions of this title.'.
(b) SATISFACTION OF ERISA
CLAIMS PROCEDURE REQUIREMENT- Section 503 of such Act (29 U.S.C. 1133) is amended
by inserting `(a)' after `SEC. 503.' and by adding at the end the following
new subsection:
`(b) In the case of a
group health plan (as defined in section 733) compliance with the requirements
of subtitle D (and section 115) of title I of the Patients' Bill of Rights Act
of 1998 in the case of a claims denial shall be deemed compliance with subsection
(a) with respect to such claims denial.'.
(c) CONFORMING AMENDMENTS-
(1) Section 732(a) of such Act (29 U.S.C. 1185(a)) is amended by striking `section
711' and inserting `sections 711 and 713'.
(2) The table of contents
in section 1 of such Act is amended by inserting after the item relating to
section 712 the following new item:
`Sec. 713. Patient
protection standards.'.
(3) Section 502(b)(3)
of such Act (29 U.S.C. 1132(b)(3)) is amended by inserting `(other than section
144(b))' after `part 7'.
SEC. 302. ERISA PREEMPTION
NOT TO APPLY TO CERTAIN ACTIONS INVOLVING HEALTH INSURANCE POLICYHOLDERS.
(a) IN GENERAL- Section
514 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1144)
is amended by adding at the end the following subsection:
`(e) PREEMPTION NOT TO
APPLY TO CERTAIN ACTIONS ARISING OUT OF PROVISION OF HEALTH BENEFITS-
`(1) IN GENERAL- Except
as provided in this subsection, nothing in this title shall be construed to
invalidate, impair, or supersede any cause of action under State law to recover
damages resulting from personal injury or for wrongful death against any person--
`(A) in connection
with the provision of insurance, administrative services, or medical services
by such person to or for a group health plan (as defined in section 733),
or
`(B) that arises
out of the arrangement by such person for the provision of such insurance,
administrative services, or medical services by other persons.
`(2) EXCEPTION FOR
EMPLOYERS AND OTHER PLAN SPONSORS-
`(A) IN GENERAL-
Subject to subparagraph (B), paragraph (1) does not authorize--
`(i) any cause
of action against an employer or other plan sponsor maintaining the group
health plan, or
`(ii) a right of
recovery or indemnity by a person against an employer or other plan sponsor
for damages assessed against the person pursuant to a cause of action
under paragraph (1).
`(B) SPECIAL RULE-
Subparagraph (A) shall not preclude any cause of action described in paragraph
(1) against an employer or other plan sponsor if--
`(i) such action
is based on the employer's or other plan sponsor's exercise of discretionary
authority to make a decision on a claim for benefits covered under the
plan or health insurance coverage in the case at issue; and
`(ii) the exercise
by such employer or other plan sponsor of such authority resulted in personal
injury or wrongful death.'.
(b) EFFECTIVE DATE- The
amendment made by subsection (a) shall apply to acts and omissions occurring
on or after the date of the enactment of this Act from which a cause of action
arises.
TITLE IV--EFFECTIVE
DATES; COORDINATION IN IMPLEMENTATION.
SEC. 401. EFFECTIVE
DATES.
(a) GROUP HEALTH COVERAGE-
(1) IN GENERAL- Subject
to paragraph (2), the amendments made by sections 201(a) and 301 (and title
I insofar as it relates to such sections) shall apply with respect to group
health plans, and health insurance coverage offered in connection with group
health plans, for plan years beginning on or after January 1, 1999 (in this
section referred to as the `general effective date') and also shall apply
to portions of plan years occurring on and after such date.
(2) TREATMENT OF COLLECTIVE
BARGAINING AGREEMENTS- In the case of a group health plan maintained pursuant
to 1 or more collective bargaining agreements between employee representatives
and 1 or more employers ratified before the date of enactment of this Act,
the amendments made by sections 201(a) and 301 (and title I insofar as it
relates to such sections) shall not apply to plan years beginning before the
later of--
(A) the date on which
the last collective bargaining agreements relating to the plan terminates
(determined without regard to any extension thereof agreed to after the
date of enactment of this Act), or
(B) the general effective
date.
For purposes of subparagraph
(A), any plan amendment made pursuant to a collective bargaining agreement
relating to the plan which amends the plan solely to conform to any requirement
added by this Act shall not be treated as a termination of such collective
bargaining agreement.
(b) INDIVIDUAL HEALTH
INSURANCE COVERAGE- The amendments made by section 202 shall apply with respect
to individual health insurance coverage offered, sold, issued, renewed, in effect,
or operated in the individual market on or after the general effective date.
SEC. 402. COORDINATION
IN IMPLEMENTATION.
Section 104(1) of Health
Insurance Portability and Accountability Act of 1996 is amended by inserting
`or under title I of the Patients' Bill of Rights Act of 1998 (and the amendments
made by such Act)' after `section 401)'.
END
